Summary:
The Validation Specialist will support the validation of the new Glassware Washer in the QC Laboratory of a pharmaceutical industry in Barceloneta, PR.   This full time and full on-site project assignment will support an ongoing project.  Proven experience in Glass Washer equipment and process validation is required.

System to be used: Miele Model PLW 8615.  This is a Laboratory Glassware Washer designed to cleaning, rinsing, and drying of llaboratory glassware, utensils and similar categorized components using water-based media.

Responsibilities:

1. LEVA Documentation, Discrepancy and Risk Assessment:  Develop all validation deliverables not limited to the following:  Roles Assignment Log, Validation Plan, User Requirements, Risk Assessment, Configuration Specifications, Part 11 Assessment, URS, IOQ, PQ, Validation Summary Report and other) for the validation of Equipment.
2. Vendor Equipment Start up and IOQ Execution:  Support during Vendor Start up and vendor IOQ Execution.
3. SOP:  Generation of Operational and administration Procedures.
4. PM, Calibration and Spare Parts:  Incorporate equipment in PM, CAL & Spare Parts Program.
5. Generate Weekly Reports:  Project Status Report
6. Support Any Drawings Update:  Redlines of Drawings
7. Support other tasks as assigned.

Requirements:

• Bachelor´s degree in Science, Engineering or Administration
• 3-5 years of direct related experience in validation of Glassware Washers or similar equipment to be used in a GxP process - Laboratory area in a pharmaceutical manufacturing environment.
• Good technical skills, able to learn the new technology and good communication and organization skills. 

Work Methodology:

• Full time, full on site assignment in Barceloneta, PR
• Professional services contract classification
• 3 months of this first assignment
• Administrative shift and willing to work non administrative hours.